12/02/19

Section 101: What’s Left To Patent In The Life Sciences After Myriad, Mayo, And Alice?


Warren D. Woessner and Robin A. Chadwick, Schwegman, Lundberg & Woessner, P.A.

Section 101 of the Patent Act (the Act) states that the following categories of invention are eligible for patent protection, so long as the other standards of patentability are met: processes, machines, manufactures, and compositions of matter, as well as improvements thereof. In 1980, the Supreme Court ruled that a man-made microorganism was also eligible for patent protection under Section 101, reaffirming at the same time that no patents should be granted on laws of nature, physical phenomena and abstract ideas. Instead, the Court emphasized that patent-eligible inventions must be generated by human ingenuity. Apart from its decision in 2001 that plants were also eligible for patenting, the Supreme Court had not again addressed whether living organisms, or their natural components, were patent eligible until 2012.

Although the courts have grappled for years with the “abstractness” of software claims, after about 2010 the courts turned their attention to life sciences patents, finding that many diagnostic claims were patent-ineligible as abstract ideas, while others were patent-ineligible for patenting as embracing natural phenomena. Shortly after the Bilski decision held that claims to a method of hedging commodity risk were patent-ineligible under Section 101 as an attempt to patent an abstract idea, the Supreme Court granted certiorari and remanded the Classen case involving an appeal of claims to immunization schedules, and then decided two biotech/pharma cases, the Mayo case in 2012 and the Myriad case in 2013. The application of the Supreme Court’s Mayo decision by the Federal Circuit to the prenatal testing claims in the PerkinElmer case and in the Ariosa case, as well as the Federal Circuit’s own rejection of the Myriad diagnostic claims suggests that claims directed to the use of biomarkers in personalized medicine have increasingly become vulnerable to attack by litigants as not constituting patent-eligible inventions. The recent Athena case further confirms the court’s stance against the patent eligibility of diagnostic claims. The U.S. Patent and Trademark Office has also issued a series of their own Memoranda outlining the patent eligibility of natural products, natural phenomena, and laws of nature. 

This paper discusses and reflects on what the courts and the Patent Office have said illustrating the recent evolution of biotechnology-related court decisions on patent eligibility. A table is provided at the end of the chapter showing the language of various biotech patent claims and how the courts have ruled.

101 J. Pat. & Trademark Off. Soc’y 121(2019)

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